II
Calendar No. 18
119THCONGRESS
1
STSESSION S. 331
To amend the Controlled Substances Act with respect to the scheduling
of fentanyl-related substances, and for other purposes.
IN THE SENATE OF THE UNITED STATES
JANUARY30, 2025
Mr. C
ASSIDY(for himself, Mr. HEINRICH, Mr. GRASSLEY, Mr. MARSHALL,
Mr. Y
OUNG, Mr. DAINES, Mr. ROUNDS, Mrs. CAPITO, Mr. SCHMITT, Mr.
K
ENNEDY, Mr. GALLEGO, Ms. HASSAN, Ms. CORTEZMASTO, Mrs. SHA-
HEEN, Mr. KING, Mr. KELLY, Mr. CORNYN, Mr. HAWLEY, Mr. TILLIS,
Mr. G
RAHAM, Mr. CRUZ, Mrs. BRITT, Mrs. BLACKBURN, Mr. LEE, and
Mrs. M
OODY) introduced the following bill; which was read twice and re-
ferred to the Committee on the Judiciary
M
ARCH3, 2025
Reported by Mr. G
RASSLEY, with an amendment
[Strike out all after the enacting clause and insert the part printed in italic]
A BILL
To amend the Controlled Substances Act with respect to
the scheduling of fentanyl-related substances, and for
other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
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SECTION1.SHORTTITLE. 1
ThisActmaybecitedasthe‘‘HaltAllLethalTraf-2
fickingofFentanylAct’’orthe‘‘HALTFentanylAct’’. 3
SEC.2.CLASSSCHEDULING OFFENTANYL-RELATED SUB-4
STANCES. 5
Section202(c)oftheControlledSubstancesAct(21 6
U.S.C.812(c))isamendedbyaddingattheendofsched-7
uleIthefollowing: 8
‘‘(e)(1)Unlessspecificallyexemptedorunlesslisted 9
inanotherschedule,anymaterial,compound,mixture,or 10
preparationwhichcontainsanyquantityofafentanyl-re-11
latedsubstance,orwhichcontainsthesalts,isomers,and 12
saltsofisomersofafentanyl-relatedsubstancewhenever 13
theexistenceofsuchsalts,isomers,andsaltsofisomers 14
ispossiblewithinthespecificchemicaldesignation. 15
‘‘(2)Forpurposesofparagraph(1),exceptaspro-16
videdinparagraph(3),theterm‘fentanyl-relatedsub-17
stance’meansanysubstancethatisstructurallyrelated 18
tofentanylby1ormoreofthefollowingmodifications: 19
‘‘(A)Byreplacementofthephenylportionof 20
thephenethylgroupbyanymonocycle,whetheror 21
notfurthersubstitutedinoronthemonocycle. 22
‘‘(B)Bysubstitutioninoronthephenethyl 23
groupwithalkyl,alkenyl,alkoxyl,hydroxyl,halo, 24
haloalkyl,amino,ornitrogroups. 25
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‘‘(C)Bysubstitutioninoronthepiperidine 1
ringwithalkyl,alkenyl,alkoxyl,ester,ether, 2
hydroxyl,halo,haloalkyl,amino,ornitrogroups. 3
‘‘(D)Byreplacementoftheanilineringwith 4
anyaromaticmonocyclewhetherornotfurthersub-5
stitutedinoronthearomaticmonocycle. 6
‘‘(E)ByreplacementoftheN–propionylgroup 7
withanotheracylgroup. 8
‘‘(3)Asubstancethatsatisfiesthedefinitionofthe 9
term‘fentanyl-relatedsubstance’inparagraph(2)shall 10
nonethelessnotbetreatedasafentanyl-relatedsubstance 11
subjecttothisscheduleifthesubstance— 12
‘‘(A)iscontrolledbyactionoftheAttorney 13
Generalundersection201;or 14
‘‘(B)isotherwiseexpresslylistedinaschedule 15
otherthanthisschedule. 16
‘‘(4)(A)TheAttorneyGeneralmaybyorderpublish 17
intheFederalRegisteralistofsubstancesthatsatisfy 18
thedefinitionoftheterm‘fentanyl-relatedsubstance’in 19
paragraph(2). 20
‘‘(B)Theabsenceofasubstancefromalistpublished 21
undersubparagraph(A)doesnotnegatethecontrolstatus 22
ofthesubstanceunderthisscheduleifthesubstancesatis-23
fiesthedefinitionoftheterm‘fentanyl-relatedsubstance’ 24
inparagraph(2).’’. 25
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SEC.3.REGISTRATION REQUIREMENTS RELATED TORE-1
SEARCH. 2
(a)ALTERNATIVE REGISTRATIONPROCESSFOR 3
SCHEDULEIRESEARCH.—Section303oftheControlled 4
SubstancesAct(21U.S.C.823)isamended— 5
(1)byredesignatingthesecondsubsection(l) 6
(relatingtorequiredtrainingforprescribers)assub-7
section(m);and 8
(2)byaddingattheendthefollowing: 9
‘‘(n)SPECIALPROVISIONSFORPRACTITIONERS 10
CONDUCTINGCERTAINRESEARCHWITHSCHEDULEI 11
CONTROLLEDSUBSTANCES.— 12
‘‘(1)INGENERAL.—Notwithstandingsubsection 13
(g),apractitionermayconductresearchdescribedin 14
paragraph(2)ofthissubsectionwith1ormore 15
scheduleIsubstancesinaccordancewithsubpara-16
graph(A)or(B)ofparagraph(3)ofthissub-17
section. 18
‘‘(2)RESEARCHSUBJECTTOEXPEDITED PRO-19
CEDURES.—Researchdescribedinthisparagraphis 20
researchthat— 21
‘‘(A)iswithrespecttoadrugthatisthe 22
subjectofaninvestigationaluseexemption 23
undersection505(i)oftheFederalFood,Drug, 24
andCosmeticAct(21U.S.C.355(i));or 25
‘‘(B)is— 26
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‘‘(i)conductedbytheDepartmentof 1
HealthandHumanServices,theDepart-2
mentofDefense,ortheDepartmentof 3
VeteransAffairs;or 4
‘‘(ii)fundedpartlyorentirelybya 5
grant,contract,cooperativeagreement,or 6
othertransactionfromtheDepartmentof 7
HealthandHumanServices,theDepart-8
mentofDefense,ortheDepartmentof 9
VeteransAffairs. 10
‘‘(3)EXPEDITEDPROCEDURES.— 11
‘‘(A)RESEARCHER WITHACURRENT 12
SCHEDULE IORIIRESEARCHREGISTRATION.— 13
‘‘(i)INGENERAL.—Ifapractitioneris 14
registeredtoconductresearchwithacon-15
trolledsubstanceinscheduleIorII,the 16
practitionermayconductresearchunder 17
thissubsectiononandafterthedatethat 18
is30daysafterthedateonwhichthe 19
practitionersendsanoticetotheAttorney 20
Generalcontainingthefollowinginforma-21
tion,withrespecttoeachsubstancewith 22
whichthepractitionerwillconductthere-23
search: 24
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‘‘(I)Thechemicalnameofthe 1
substance. 2
‘‘(II)Thequantityofthesub-3
stancetobeusedintheresearch. 4
‘‘(III)Demonstrationthatthere-5
searchisinthecategorydescribedin 6
paragraph(2),whichdemonstration 7
maybesatisfied— 8
‘‘(aa)inthecaseofagrant, 9
contract,cooperativeagreement, 10
orothertransaction,orintra-11
muralresearchproject,byidenti-12
fyingthesponsoringagencyand 13
supplyingthenumberofthe 14
grant,contract,cooperative 15
agreement,othertransaction,or 16
project;or 17
‘‘(bb)inthecaseofanap-18
plicationundersection505(i)of 19
theFederalFood,Drug,and 20
CosmeticAct(21U.S.C.355(i)), 21
bysupplyingtheapplication 22
numberandthesponsorof 23
recordontheapplication. 24
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‘‘(IV)Demonstrationthatthere-1
searcherisauthorizedtoconductre-2
searchwithrespecttothesubstance 3
underthelawsoftheStateinwhich 4
theresearchwilltakeplace. 5
‘‘(ii)VERIFICATIONOFINFORMATION 6
BYHHSORVA.—Uponrequestfromthe 7
AttorneyGeneral,theSecretaryofHealth 8
andHumanServices,theDepartmentof 9
Defense,ortheSecretaryofVeteransAf-10
fairs,asappropriate,shallverifyinforma-11
tionsubmittedbyanapplicantunder 12
clause(i)(III). 13
‘‘(B)RESEARCHER WITHOUT ACURRENT 14
SCHEDULE IORIIRESEARCHREGISTRATION.— 15
‘‘(i)INGENERAL.—Ifapractitioneris 16
notregisteredtoconductresearchwitha 17
controlledsubstanceinscheduleIorII, 18
thepractitionermaysendanoticetothe 19
AttorneyGeneralcontainingtheinforma-20
tionlistedinsubparagraph(A)(i),withre-21
specttoeachsubstancewithwhichthe 22
practitionerwillconducttheresearch. 23
‘‘(ii)ATTORNEYGENERALACTION.— 24
TheAttorneyGeneralshall— 25
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‘‘(I)treatnoticereceivedunder 1
clause(i)asasufficientapplication 2
foraresearchregistration;and 3
‘‘(II)notlaterthan45daysof 4
receivingsuchanoticethatcontains 5
allinformationrequiredundersub-6
paragraph(A)(i)— 7
‘‘(aa)registertheapplicant; 8
or 9
‘‘(bb)serveanordertoshow 10
causeupontheapplicantinac-11
cordancewithsection304(c). 12
‘‘(4)ELECTRONICSUBMISSIONS.—TheAttorney 13
Generalshallprovideameanstopermitapracti-14
tionertosubmitanotificationunderparagraph(3) 15
electronically. 16
‘‘(5)LIMITATIONONAMOUNTS.—Apractitioner 17
conductingresearchwithascheduleIsubstance 18
underthissubsectionmayonlypossesstheamounts 19
ofscheduleIsubstanceidentifiedin— 20
‘‘(A)thenotificationtotheAttorneyGen-21
eralunderparagraph(3);or 22
‘‘(B)asupplementalnotificationthatthe 23
practitionermaysendifthepractitionerneeds 24
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additionalamountsfortheresearch,whichsup-1
plementalnotificationshallinclude— 2
‘‘(i)thenameofthepractitioner; 3
‘‘(ii)theadditionalquantityneededof 4
thesubstance;and 5
‘‘(iii)anattestationthattheresearch 6
tobeconductedwiththesubstanceiscon-7
sistentwiththescopeoftheresearchthat 8
wasthesubjectofthenotificationunder 9
paragraph(3). 10
‘‘(6)IMPORTATION ANDEXPORTATION RE-11
QUIREMENTS NOTAFFECTED.—Nothinginthissub-12
sectionalterstherequirementsofpartAoftitleIII, 13
regardingtheimportationandexportationofcon-14
trolledsubstances. 15
‘‘(7)INSPECTORGENERALREPORT.—Notlater 16
than1yearafterthedateofenactmentoftheHalt 17
AllLethalTraffickingofFentanylAct,theInspec-18
torGeneraloftheDepartmentofJusticeshallcom-19
pleteastudy,andsubmittoCongressareport 20
thereon,aboutresearchdescribedinparagraph(2) 21
ofthissubsectionwithfentanyl.’’. 22
(b)SEPARATEREGISTRATIONSNOTREQUIREDFOR 23
ADDITIONALRESEARCHERINSAMEINSTITUTION.— 24
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(1)INGENERAL.—Section302(c)oftheCon-1
trolledSubstancesAct(21U.S.C.822(c))isamend-2
edbyaddingattheendthefollowing: 3
‘‘(4)Anagentoremployeeofaresearchinsti-4
tutionthatisconductingresearchwithacontrolled 5
substanceif— 6
‘‘(A)theagentoremployeeisactingwith-7
inthescopeoftheprofessionalpracticeofthe 8
agentoremployee; 9
‘‘(B)anotheragentoremployeeofthein-10
stitutionisregisteredtoconductresearchwith 11
acontrolledsubstanceinthesameschedule; 12
‘‘(C)theresearcherwhoissoregistered— 13
‘‘(i)informstheAttorneyGeneralof 14
thename,positiontitle,andemployingin-15
stitutionoftheagentoremployeewhois 16
notseparatelyregistered; 17
‘‘(ii)authorizesthatagentorem-18
ployeetoperformresearchunderthereg-19
istrationoftheregisteredresearcher;and 20
‘‘(iii)affirmsthatanyacttakenby 21
thatagentoremployeeinvolvingacon-22
trolledsubstanceshallbeattributableto 23
theregisteredresearcher,asifthere-24
searcherhaddirectlycommittedtheact, 25
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forpurposesofanyproceedingundersec-1
tion304(a)tosuspendorrevokethereg-2
istrationoftheregisteredresearcher;and 3
‘‘(D)theAttorneyGeneraldoesnot,within 4
30daysofreceivingtheinformation,authoriza-5
tion,andaffirmationdescribedinsubparagraph 6
(C),refuse,forareasonlistedinsection 7
304(a),toallowtheagentoremployeetopos-8
sessthesubstancewithoutaseparateregistra-9
tion.’’. 10
(2)TECHNICAL CORRECTION.—Section 11
302(c)(3)oftheControlledSubstancesAct(21 12
U.S.C.822(c)(3))isamendedbystriking‘‘(25)’’ 13
andinserting‘‘(27)’’. 14
(c)SINGLEREGISTRATIONFORRELATEDRESEARCH 15
SITES.—Section302(e)oftheControlledSubstancesAct 16
(21U.S.C.822(e))isamendedbyaddingattheendthe 17
following: 18
‘‘(4)(A)Notwithstandingparagraph(1),aperson 19
registeredtoconductresearchwithacontrolledsubstance 20
undersection303(g)mayconducttheresearchundera 21
singleregistrationif— 22
‘‘(i)theresearchoccursexclusivelyonsitesall 23
ofwhichare— 24
‘‘(I)withinthesamecityorcounty;and 25
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‘‘(II)underthecontrolofthesameinstitu-1
tion,organization,oragency;and 2
‘‘(ii)beforecommencingtheresearch,there-3
searchernotifiestheAttorneyGeneralofeachsite 4
where— 5
‘‘(I)theresearchwillbeconducted;or 6
‘‘(II)thecontrolledsubstancewillbe 7
storedoradministered. 8
‘‘(B)Asitedescribedinsubparagraph(A)shallbe 9
includedinaregistrationdescribedinthatsubparagraph 10
onlyiftheresearcherhasnotifiedtheAttorneyGeneral 11
ofthesite— 12
‘‘(i)intheapplicationfortheregistration;or 13
‘‘(ii)beforetheresearchisconducted,orbefore 14
thecontrolledsubstanceisstoredoradministered,at 15
thesite. 16
‘‘(C)TheAttorneyGeneralmay,inconsultationwith 17
theSecretary,issueregulationsaddressing,withrespect 18
toresearchsitesdescribedinsubparagraph(A)— 19
‘‘(i)themannerinwhichcontrolledsubstances 20
maybedeliveredtotheresearchsites; 21
‘‘(ii)thestorageandsecurityofcontrolledsub-22
stancesattheresearchsites; 23
‘‘(iii)themaintenanceofrecordsforthere-24
searchsites;and 25
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‘‘(iv)anyothermattersnecessarytoensureef-1
fectivecontrolsagainstdiversionattheresearch 2
sites.’’. 3
(d)NEWINSPECTIONNOTREQUIREDINCERTAIN 4
SITUATIONS.—Section302(f)oftheControlledSub-5
stancesAct(21U.S.C.822(f))isamended— 6
(1)bystriking‘‘(f)The’’andinserting‘‘(f)(1) 7
The’’;and 8
(2)byaddingattheendthefollowing: 9
‘‘(2)(A)Ifapersonisregisteredtoconductresearch 10
withacontrolledsubstanceandappliesforaregistration, 11
orforamodificationofaregistration,toconductresearch 12
withasecondcontrolledsubstancethatisinthesame 13
scheduleasthefirstcontrolledsubstance,orisinasched-14
ulewithahighernumericaldesignationthantheschedule 15
ofthefirstcontrolledsubstance,anewinspectionbythe 16
AttorneyGeneraloftheregisteredlocationisnotrequired. 17
‘‘(B)Nothinginsubparagraph(A)shallprohibitthe 18
AttorneyGeneralfromconductinganinspectionthatthe 19
AttorneyGeneraldeterminesnecessarytoensurethata 20
registrantmaintainseffectivecontrolsagainstdiversion.’’. 21
(e)CONTINUATION OFRESEARCHONSUBSTANCES 22
NEWLYADDEDTOSCHEDULEI.—Section302ofthe 23
ControlledSubstancesAct(21U.S.C.822)isamended 24
byaddingattheendthefollowing: 25
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‘‘(h)CONTINUATION OFRESEARCHONSUBSTANCES 1
NEWLYADDEDTOSCHEDULEI.—Ifapersoniscon-2
ductingresearchonasubstancewhenthesubstanceis 3
addedtoscheduleI,andthepersonisalreadyregistered 4
toconductresearchwithacontrolledsubstanceinsched-5
uleI— 6
‘‘(1)notlaterthan90daysafterthescheduling 7
ofthenewlyscheduledsubstance,thepersonshall 8
submitacompletedapplicationforregistrationor 9
modificationofexistingregistration,toconductre-10
searchonthesubstance,inaccordancewithregula-11
tionsissuedbytheAttorneyGeneralforpurposesof 12
thisparagraph; 13
‘‘(2)thepersonmay,notwithstandingsub-14
sections(a)and(b),continuetoconductthere-15
searchonthesubstanceuntil— 16
‘‘(A)thepersonwithdrawstheapplication 17
describedinparagraph(1)ofthissubsection; 18
or 19
‘‘(B)theAttorneyGeneralservesonthe 20
personanordertoshowcauseproposingthe 21
denialoftheapplicationundersection304(c); 22
‘‘(3)iftheAttorneyGeneralservesanorderto 23
showcauseasdescribedinparagraph(2)(B)and 24
thepersonrequestsahearing,thehearingshallbe 25
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heldonanexpeditedbasisandnotlaterthan45 1
daysaftertherequestismade,exceptthatthehear-2
ingmaybeheldatalatertimeifsorequestedby 3
theperson;and 4
‘‘(4)ifthepersonsendsacopyoftheapplica-5
tiondescribedinparagraph(1)toamanufactureror 6
distributorofthesubstance,receiptofthecopyby 7
themanufacturerordistributorshallconstitutesuf-8
ficientevidencethatthepersonisauthorizedtore-9
ceivethesubstance.’’. 10
(f)TREATMENT OFCERTAINMANUFACTURING AC-11
TIVITIESASCOINCIDENTTORESEARCH.—Section302of 12
theControlledSubstancesAct(21U.S.C.822),asamend-13
edbysubsection(e),isamendedbyaddingattheend 14
thefollowing: 15
‘‘(i)TREATMENT OFCERTAINMANUFACTURINGAC-16
TIVITIESASCOINCIDENTTORESEARCH.— 17
‘‘(1)INGENERAL.—Exceptasprovidedinpara-18
graph(3),apersonwhoisregisteredtoperformre-19
searchonacontrolledsubstancemayperformmanu-20
facturingactivitieswithsmallquantitiesofthatsub-21
stance,includingactivitiesdescribedinparagraph 22
(2),withoutbeingrequiredtoobtainamanufac-23
turingregistration,if— 24
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‘‘(A)theactivitiesareperformedforthe 1
purposeoftheresearch;and 2
‘‘(B)theactivitiesandthequantitiesof 3
thesubstanceinvolvedintheactivitiesarestat-4
edin— 5
‘‘(i)anotificationsubmittedtothe 6
AttorneyGeneralundersection303(n); 7
‘‘(ii)aresearchprotocolfiledwithan 8
applicationforregistrationapprovalunder 9
section303(g);or 10
‘‘(iii)anotificationtotheAttorney 11
Generalthatincludes— 12
‘‘(I)thenameoftheregistrant; 13
and 14
‘‘(II)anattestationthatthere-15
searchtobeconductedwiththesmall 16
quantitiesofmanufacturedsubstance 17
isconsistentwiththescopeofthere-18
searchthatisthebasisforthereg-19
istration. 20
‘‘(2)ACTIVITIESINCLUDED.—Activitiesper-21
mittedunderparagraph(1)include— 22
‘‘(A)processingthesubstancetocreateex-23
tracts,tinctures,oils,solutions,derivatives,or 24
otherformsofthesubstanceconsistentwith— 25
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‘‘(i)theinformationprovidedaspart 1
ofanotificationsubmittedtotheAttorney 2
Generalundersection303(n);or 3
‘‘(ii)aresearchprotocolfiledwithan 4
applicationforregistrationapprovalunder 5
section303(g);and 6
‘‘(B)dosageformdevelopmentstudiesper-7
formedforthepurposeofrequestinganinves-8
tigationalnewdrugexemptionundersection 9
505(i)oftheFederalFood,Drug,andCos-10
meticAct(21U.S.C.355(i)). 11
‘‘(3)EXCEPTION REGARDING MARIHUANA.— 12
Theauthorityunderparagraph(1)tomanufacture 13
substancesdoesnotincludetheauthoritytogrow 14
marihuana.’’. 15
(g)TRANSPARENCY REGARDINGSPECIALPROCE-16
DURES.—Section303oftheControlledSubstancesAct 17
(21U.S.C.823),asamendedbysubsection(a),isamend-18
edbyaddingattheendthefollowing: 19
‘‘(o)TRANSPARENCY REGARDINGSPECIALPROCE-20
DURES.— 21
‘‘(1)INGENERAL.—IftheAttorneyGeneralde-22
termines,withrespecttoacontrolledsubstance,that 23
anapplicationbyapractitionertoconductresearch 24
withthesubstanceshouldbeconsideredundera 25
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process,orsubjecttocriteria,differentfromthe 1
processorcriteriaapplicabletoapplicationstocon-2
ductresearchwithothercontrolledsubstancesinthe 3
sameschedule,theAttorneyGeneralshallmake 4
public,includingbypostingonthewebsiteofthe 5
DrugEnforcementAdministration— 6
‘‘(A)theidentitiesofallsubstancesfor 7
whichsuchdeterminationshavebeenmade; 8
‘‘(B)theprocessandcriteriathatshallbe 9
appliedtoapplicationstoconductresearchwith 10
thosesubstances;and 11
‘‘(C)howtheprocessandcriteriadescribed 12
insubparagraph(B)differfromtheprocess 13
andcriteriaapplicabletoapplicationstocon-14
ductresearchwithothercontrolledsubstances 15
inthesameschedule. 16
‘‘(2)TIMINGOFPOSTING.—TheAttorneyGen-17
eralshallmakeinformationdescribedinparagraph 18
(1)publicuponmakingadeterminationdescribedin 19
thatparagraph,regardlessofwhetherapractitioner 20
hassubmittedsuchanapplicationatthattime.’’. 21
SEC.4.TECHNICAL CORRECTION ONCONTROLLED SUB-22
STANCES DISPENSING. 23
EffectiveasifincludedintheenactmentofPublic 24
Law117–328— 25
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(1)section1252(a)ofdivisionFFofPublic 1
Law117–328(136Stat.5681)isamended,inthe 2
matterbeinginsertedintosection302(e)oftheCon-3
trolledSubstancesAct,bystriking‘‘303(g)’’andin-4
serting‘‘303(h)’’; 5
(2)section1262ofdivisionFFofPublicLaw 6
117–328(136Stat.5681)isamended— 7
(A)insubsection(a)— 8
(i)inthematterprecedingparagraph 9
(1),bystriking‘‘303(g)’’andinserting 10
‘‘303(h)’’; 11
(ii)inthematterbeingstrickenby 12
subsection(a)(2),bystriking‘‘(g)(1)’’and 13
inserting‘‘(h)(1)’’;and 14
(iii)inthematterbeinginsertedby 15
subsection(a)(2),bystriking‘‘(g)Practi-16
tioners’’andinserting‘‘(h)Practitioners’’; 17
and 18
(B)insubsection(b)— 19
(i)inthematterbeingstrickenby 20
paragraph(1),bystriking‘‘303(g)(1)’’ 21
andinserting‘‘303(h)(1)’’; 22
(ii)inthematterbeinginsertedby 23
paragraph(1),bystriking‘‘303(g)’’and 24
inserting‘‘303(h)’’; 25
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(iii)inthematterbeingstrickenby 1
paragraph(2)(A),bystriking‘‘303(g)(2)’’ 2
andinserting‘‘303(h)(2)’’; 3
(iv)inthematterbeingstrickenby 4
paragraph(3),bystriking‘‘303(g)(2)(B)’’ 5
andinserting‘‘303(h)(2)(B)’’; 6
(v)inthematterbeingstrickenby 7
paragraph(5),bystriking‘‘303(g)’’and 8
inserting‘‘303(h)’’;and 9
(vi)inthematterbeingstrickenby 10
paragraph(6),bystriking‘‘303(g)’’and 11
inserting‘‘303(h)’’;and 12
(3)section1263(b)ofdivisionFFofPublic 13
Law117–328(136Stat.5685)isamended— 14
(A)bystriking‘‘303(g)(2)’’andinserting 15
‘‘303(h)(2)’’;and 16
(B)bystriking‘‘(21U.S.C.823(g)(2))’’ 17
andinserting‘‘(21U.S.C.823(h)(2))’’. 18
SEC.5.RULEMAKING. 19
(a)INTERIMFINALRULES.—TheAttorneyGen-20
eral— 21
(1)shall,notlaterthan6monthsafterthedate 22
ofenactmentofthisAct,issuerulestoimplement 23
thisActandtheamendmentsmadebythisAct;and 24
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(2)mayissuetherulesunderparagraph(1)as 1
interimfinalrules. 2
(b)PROCEDUREFORFINALRULE.— 3
(1)EFFECTIVENESS OFINTERIM FINAL 4
RULES.—AruleissuedbytheAttorneyGeneralas 5
aninterimfinalruleundersubsection(a)shallbe-6
comeimmediatelyeffectiveasaninterimfinalrule 7
withoutrequiringtheAttorneyGeneraltodem-8
onstrategoodcausetherefor,notwithstandingsub-9
paragraph(B)ofsection553(b)oftitle5,United 10
StatesCode. 11
(2)OPPORTUNITY FORCOMMENT ANDHEAR-12
ING.—Aninterimfinalruleissuedundersubsection 13
(a)shallgiveinterestedpersonstheopportunityto 14
commentandtorequestahearing. 15
(3)FINALRULE.—Aftertheconclusionofsuch 16
proceedings,theAttorneyGeneralshallissueafinal 17
ruletoimplementthisActandtheamendments 18
madebythisActinaccordancewithsection553of 19
title5,UnitedStatesCode. 20
SEC.6.PENALTIES. 21
(a)INGENERAL.—Section401(b)(1)oftheCon-22
trolledSubstancesAct(21U.S.C.841(b)(1))isamend-23
ed— 24
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(1)insubparagraph(A)(vi),byinserting‘‘ora 1
fentanyl-relatedsubstance’’after‘‘anyanalogueof 2
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 3
propanamide’’;and 4
(2)insubparagraph(B)(vi),byinserting‘‘ora 5
fentanyl-relatedsubstance’’after‘‘anyanalogueof 6
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 7
propanamide’’. 8
(b)IMPORTATION ANDEXPORTATION.—Section 9
1010(b)oftheControlledSubstancesImportandExport 10
Act(21U.S.C.960(b))isamended— 11
(1)inparagraph(1)(F),byinserting‘‘ora 12
fentanyl-relatedsubstance’’after‘‘anyanalogueof 13
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 14
propanamide’’;and 15
(2)inparagraph(2)(F),byinserting‘‘ora 16
fentanyl-relatedsubstance’’after‘‘anyanalogueof 17
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 18
propanamide’’. 19
(c)DEFINITION OFFENTANYL-RELATEDSUB-20
STANCE.—Section102oftheControlledSubstancesAct 21
(21U.S.C.802)isamendedbyaddingattheendthefol-22
lowing: 23
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‘‘(60)Theterm‘fentanyl-relatedsubstance’hasthe 1
meaninggiventheterminsubsection(e)(2)ofschedule 2
Iofsection202(c).’’. 3
SEC.7.APPLICABILITY; OTHERMATTERS. 4
(a)INGENERAL.—Irrespectiveofthedateonwhich 5
therulesrequiredbysection4arefinalized,theamend-6
mentsmadebythisActapplybeginningasofthedate 7
ofenactmentofthisAct. 8
(b)RULEOFCONSTRUCTION.—Nothinginthe 9
amendmentsmadebythisActmaybeconstruedasevi-10
dencethat,inapplyingsections401(b)(1)and1010(b)of 11
theControlledSubstancesAct(21U.S.C.841(b)(1), 12
960(b))withrespecttoconductoccurringbeforethedate 13
oftheenactmentofthisAct,afentanyl-relatedsubstance 14
(asdefinedbysuchamendments)isnotananalogueof 15
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 16
propanamide. 17
(c)SENSEOFCONGRESS.—Congressagreeswiththe 18
interpretationoftheControlledSubstancesAct(21 19
U.S.C.801etseq.)inUnitedStatesv.McCray,346F. 20
Supp.3d363(W.D.N.Y.2018). 21
SECTION 1. SHORT TITLE. 22
This Act may be cited as the ‘‘Halt All Lethal Traf-23
ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 24
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SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-1
STANCES. 2
Section 202(c) of the Controlled Substances Act (21 3
U.S.C. 812(c)) is amended by adding at the end of schedule 4
I the following: 5
‘‘(e)(1) Unless specifically exempted or unless listed in 6
another schedule, any material, compound, mixture, or 7
preparation which contains any quantity of a fentanyl-re-8
lated substance, or which contains the salts, isomers, and 9
salts of isomers of a fentanyl-related substance whenever the 10
existence of such salts, isomers, and salts of isomers is pos-11
sible within the specific chemical designation. 12
‘‘(2) For purposes of paragraph (1), except as provided 13
in paragraph (3), the term ‘fentanyl-related substance’ 14
means any substance that is structurally related to fentanyl 15
by 1 or more of the following modifications: 16
‘‘(A) By replacement of the phenyl portion of the 17
phenethyl group by any monocycle, whether or not 18
further substituted in or on the monocycle. 19
‘‘(B) By substitution in or on the phenethyl 20
group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21
haloalkyl, amino, or nitro groups. 22
‘‘(C) By substitution in or on the piperidine 23
ring with alkyl, alkenyl, alkoxyl, ester, ether, 24
hydroxyl, halo, haloalkyl, amino, or nitro groups. 25
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‘‘(D) By replacement of the aniline ring with 1
any aromatic monocycle whether or not further sub-2
stituted in or on the aromatic monocycle. 3
‘‘(E) By replacement of the N–propionyl group 4
with another acyl group. 5
‘‘(3) A substance that satisfies the definition of the 6
term ‘fentanyl-related substance’ in paragraph (2) shall 7
nonetheless not be treated as a fentanyl-related substance 8
subject to this schedule if the substance— 9
‘‘(A) is controlled by action of the Attorney Gen-10
eral under section 201; or 11
‘‘(B) is otherwise expressly listed in a schedule 12
other than this schedule. 13
‘‘(4)(A) The Attorney General may by order publish 14
in the Federal Register a list of substances that satisfy the 15
definition of the term ‘fentanyl-related substance’ in para-16
graph (2). 17
‘‘(B) The absence of a substance from a list published 18
under subparagraph (A) does not negate the control status 19
of the substance under this schedule if the substance satisfies 20
the definition of the term ‘fentanyl-related substance’ in 21
paragraph (2).’’. 22
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SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-1
SEARCH. 2
(a) A
LTERNATIVEREGISTRATIONPROCESS FOR 3
S
CHEDULEI RESEARCH.—Section 303 of the Controlled 4
Substances Act (21 U.S.C. 823) is amended— 5
(1) by redesignating the second subsection (l) (re-6
lating to required training for prescribers) as sub-7
section (m); and 8
(2) by adding at the end the following: 9
‘‘(n) S
PECIALPROVISIONS FORPRACTITIONERSCON-10
DUCTINGCERTAINRESEARCHWITHSCHEDULEI CON-11
TROLLEDSUBSTANCES.— 12
‘‘(1) I
N GENERAL.—Notwithstanding subsection 13
(g), a practitioner may conduct research described in 14
paragraph (2) of this subsection with 1 or more 15
schedule I substances in accordance with subpara-16
graph (A) or (B) of paragraph (3) of this subsection. 17
‘‘(2) R
ESEARCH SUBJECT TO EXPEDITED PROCE -18
DURES.—Research described in this paragraph is re-19
search that— 20
‘‘(A) is with respect to a drug that is the 21
subject of an investigational use exemption under 22
section 505(i) of the Federal Food, Drug, and 23
Cosmetic Act (21 U.S.C. 355(i)); or 24
‘‘(B) is— 25
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‘‘(i) conducted by the Department of 1
Health and Human Services, the Depart-2
ment of Defense, or the Department of Vet-3
erans Affairs; or 4
‘‘(ii) funded partly or entirely by a 5
grant, contract, cooperative agreement, or 6
other transaction from the Department of 7
Health and Human Services, the Depart-8
ment of Defense, or the Department of Vet-9
erans Affairs. 10
‘‘(3) E
XPEDITED PROCEDURES .— 11
‘‘(A) R
ESEARCHER WITH A CURRENT 12
SCHEDULE I OR II RESEARCH REGISTRATION .— 13
‘‘(i) I
N GENERAL.—If a practitioner is 14
registered to conduct research with a con-15
trolled substance in schedule I or II, the 16
practitioner may conduct research under 17
this subsection on and after the date that is 18
30 days after the date on which the practi-19
tioner sends a notice to the Attorney Gen-20
eral containing the following information, 21
with respect to each substance with which 22
the practitioner will conduct the research: 23
‘‘(I) The chemical name of the 24
substance. 25
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‘‘(II) The quantity of the sub-1
stance to be used in the research. 2
‘‘(III) Demonstration that the re-3
search is in the category described in 4
paragraph (2), which demonstration 5
may be satisfied— 6
‘‘(aa) in the case of a grant, 7
contract, cooperative agreement, 8
or other transaction, or intra-9
mural research project, by identi-10
fying the sponsoring agency and 11
supplying the number of the 12
grant, contract, cooperative agree-13
ment, other transaction, or 14
project; or 15
‘‘(bb) in the case of an appli-16
cation under section 505(i) of the 17
Federal Food, Drug, and Cosmetic 18
Act (21 U.S.C. 355(i)), by sup-19
plying the application number 20
and the sponsor of record on the 21
application. 22
‘‘(IV) Demonstration that the re-23
searcher is authorized to conduct re-24
search with respect to the substance 25
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under the laws of the State in which 1
the research will take place. 2
‘‘(ii) V
ERIFICATION OF INFORMATION 3
BY HHS OR VA.—Upon request from the At-4
torney General, the Secretary of Health and 5
Human Services, the Department of De-6
fense, or the Secretary of Veterans Affairs, 7
as appropriate, shall verify information 8
submitted by an applicant under clause 9
(i)(III). 10
‘‘(B) R
ESEARCHER WITHOUT A CURRENT 11
SCHEDULE I OR II RESEARCH REGISTRATION .— 12
‘‘(i) I
N GENERAL.—If a practitioner is 13
not registered to conduct research with a 14
controlled substance in schedule I or II, the 15
practitioner may send a notice to the Attor-16
ney General containing the information 17
listed in subparagraph (A)(i), with respect 18
to each substance with which the practi-19
tioner will conduct the research. 20
‘‘(ii) A
TTORNEY GENERAL ACTION .— 21
The Attorney General shall— 22
‘‘(I) treat notice received under 23
clause (i) as a sufficient application 24
for a research registration; and 25
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‘‘(II) not later than 45 days of re-1
ceiving such a notice that contains all 2
information required under subpara-3
graph (A)(i)— 4
‘‘(aa) register the applicant; 5
or 6
‘‘(bb) serve an order to show 7
cause upon the applicant in ac-8
cordance with section 304(c). 9
‘‘(4) E
LECTRONIC SUBMISSIONS.—The Attorney 10
General shall provide a means to permit a practi-11
tioner to submit a notification under paragraph (3) 12
electronically. 13
‘‘(5) L
IMITATION ON AMOUNTS .—A practitioner 14
conducting research with a schedule I substance under 15
this subsection may only possess the amounts of 16
schedule I substance identified in— 17
‘‘(A) the notification to the Attorney Gen-18
eral under paragraph (3); or 19
‘‘(B) a supplemental notification that the 20
practitioner may send if the practitioner needs 21
additional amounts for the research, which sup-22
plemental notification shall include— 23
‘‘(i) the name of the practitioner; 24
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‘‘(ii) the additional quantity needed of 1
the substance; and 2
‘‘(iii) an attestation that the research 3
to be conducted with the substance is con-4
sistent with the scope of the research that 5
was the subject of the notification under 6
paragraph (3). 7
‘‘(6) I
MPORTATION AND EXPORTATION REQUIRE -8
MENTS NOT AFFECTED .—Nothing in this subsection 9
alters the requirements of part A of title III, regard-10
ing the importation and exportation of controlled sub-11
stances. 12
‘‘(7) I
NSPECTOR GENERAL REPORT .—Not later 13
than 1 year after the date of enactment of the Halt 14
All Lethal Trafficking of Fentanyl Act, the Inspector 15
General of the Department of Justice shall complete 16
a study, and submit to Congress a report thereon, 17
about research described in paragraph (2) of this sub-18
section with fentanyl.’’. 19
(b) S
EPARATEREGISTRATIONSNOTREQUIRED FOR 20
A
DDITIONALRESEARCHER INSAMEINSTITUTION.— 21
(1) I
N GENERAL.—Section 302(c) of the Con-22
trolled Substances Act (21 U.S.C. 822(c)) is amended 23
by adding at the end the following: 24
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‘‘(4) An agent or employee of a research institu-1
tion that is conducting research with a controlled sub-2
stance if— 3
‘‘(A) the agent or employee is acting within 4
the scope of the professional practice of the agent 5
or employee; 6
‘‘(B) another agent or employee of the insti-7
tution is registered to conduct research with a 8
controlled substance in the same schedule; 9
‘‘(C) the researcher who is so registered— 10
‘‘(i) informs the Attorney General of 11
the name, position title, and employing in-12
stitution of the agent or employee who is 13
not separately registered; 14
‘‘(ii) authorizes that agent or employee 15
to perform research under the registration of 16
the registered researcher; and 17
‘‘(iii) affirms that any act taken by 18
that agent or employee involving a con-19
trolled substance shall be attributable to the 20
registered researcher, as if the researcher 21
had directly committed the act, for purposes 22
of any proceeding under section 304(a) to 23
suspend or revoke the registration of the reg-24
istered researcher; and 25
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‘‘(D) the Attorney General does not, within 1
30 days of receiving the information, authoriza-2
tion, and affirmation described in subparagraph 3
(C), refuse, for a reason listed in section 304(a), 4
to allow the agent or employee to possess the sub-5
stance without a separate registration.’’. 6
(2) T
ECHNICAL CORRECTION.—Section 302(c)(3) 7
of the Controlled Substances Act (21 U.S.C. 822(c)(3)) 8
is amended by striking ‘‘(25)’’ and inserting ‘‘(27)’’. 9
(c) S
INGLEREGISTRATION FORRELATEDRESEARCH 10
S
ITES.—Section 302(e) of the Controlled Substances Act (21 11
U.S.C. 822(e)) is amended by adding at the end the fol-12
lowing: 13
‘‘(4)(A) Notwithstanding paragraph (1), a person reg-14
istered to conduct research with a controlled substance 15
under section 303(g) may conduct the research under a sin-16
gle registration if— 17
‘‘(i) the research occurs exclusively on sites all of 18
which are— 19
‘‘(I) within the same city or county; and 20
‘‘(II) under the control of the same institu-21
tion, organization, or agency; and 22
‘‘(ii) before commencing the research, the re-23
searcher notifies the Attorney General of each site 24
where— 25
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‘‘(I) the research will be conducted; or 1
‘‘(II) the controlled substance will be stored 2
or administered. 3
‘‘(B) A site described in subparagraph (A) shall be in-4
cluded in a registration described in that subparagraph 5
only if the researcher has notified the Attorney General of 6
the site— 7
‘‘(i) in the application for the registration; or 8
‘‘(ii) before the research is conducted, or before 9
the controlled substance is stored or administered, at 10
the site. 11
‘‘(C) The Attorney General may, in consultation with 12
the Secretary, issue regulations addressing, with respect to 13
research sites described in subparagraph (A)— 14
‘‘(i) the manner in which controlled substances 15
may be delivered to the research sites; 16
‘‘(ii) the storage and security of controlled sub-17
stances at the research sites; 18
‘‘(iii) the maintenance of records for the research 19
sites; and 20
‘‘(iv) any other matters necessary to ensure effec-21
tive controls against diversion at the research sites.’’. 22
(d) N
EWINSPECTIONNOTREQUIRED INCERTAINSIT-23
UATIONS.—Section 302(f) of the Controlled Substances Act 24
(21 U.S.C. 822(f)) is amended— 25
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(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 1
The’’; and 2
(2) by adding at the end the following: 3
‘‘(2)(A) If a person is registered to conduct research 4
with a controlled substance and applies for a registration, 5
or for a modification of a registration, to conduct research 6
with a second controlled substance that is in the same sched-7
ule as the first controlled substance, or is in a schedule with 8
a higher numerical designation than the schedule of the first 9
controlled substance, a new inspection by the Attorney Gen-10
eral of the registered location is not required. 11
‘‘(B) Nothing in subparagraph (A) shall prohibit the 12
Attorney General from conducting an inspection that the 13
Attorney General determines necessary to ensure that a reg-14
istrant maintains effective controls against diversion.’’. 15
(e) C
ONTINUATION OF RESEARCH ON SUBSTANCES 16
N
EWLYADDED TOSCHEDULEI.—Section 302 of the Con-17
trolled Substances Act (21 U.S.C. 822) is amended by add-18
ing at the end the following: 19
‘‘(h) C
ONTINUATION OFRESEARCH ONSUBSTANCES 20
N
EWLYADDED TOSCHEDULEI.—If a person is conducting 21
research on a substance when the substance is added to 22
schedule I, and the person is already registered to conduct 23
research with a controlled substance in schedule I— 24
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‘‘(1) not later than 90 days after the scheduling 1
of the newly scheduled substance, the person shall sub-2
mit a completed application for registration or modi-3
fication of existing registration, to conduct research 4
on the substance, in accordance with regulations 5
issued by the Attorney General for purposes of this 6
paragraph; 7
‘‘(2) the person may, notwithstanding sub-8
sections (a) and (b), continue to conduct the research 9
on the substance until— 10
‘‘(A) the person withdraws the application 11
described in paragraph (1) of this subsection; or 12
‘‘(B) the Attorney General serves on the per-13
son an order to show cause proposing the denial 14
of the application under section 304(c); 15
‘‘(3) if the Attorney General serves an order to 16
show cause as described in paragraph (2)(B) and the 17
person requests a hearing, the hearing shall be held on 18
an expedited basis and not later than 45 days after 19
the request is made, except that the hearing may be 20
held at a later time if so requested by the person; and 21
‘‘(4) if the person sends a copy of the application 22
described in paragraph (1) to a manufacturer or dis-23
tributor of the substance, receipt of the copy by the 24
manufacturer or distributor shall constitute sufficient 25
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evidence that the person is authorized to receive the 1
substance.’’. 2
(f) T
REATMENT OFCERTAINMANUFACTURINGACTIVI-3
TIES ASCOINCIDENT TORESEARCH.—Section 302 of the 4
Controlled Substances Act (21 U.S.C. 822), as amended by 5
subsection (e), is amended by adding at the end the fol-6
lowing: 7
‘‘(i) T
REATMENT OFCERTAINMANUFACTURINGAC-8
TIVITIES ASCOINCIDENT TORESEARCH.— 9
‘‘(1) I
N GENERAL.—Except as provided in para-10
graph (3), a person who is registered to perform re-11
search on a controlled substance may perform manu-12
facturing activities with small quantities of that sub-13
stance, including activities described in paragraph 14
(2), without being required to obtain a manufac-15
turing registration, if— 16
‘‘(A) the activities are performed for the 17
purpose of the research; and 18
‘‘(B) the activities and the quantities of the 19
substance involved in the activities are stated 20
in— 21
‘‘(i) a notification submitted to the At-22
torney General under section 303(n); 23
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‘‘(ii) a research protocol filed with an 1
application for registration approval under 2
section 303(g); or 3
‘‘(iii) a notification to the Attorney 4
General that includes— 5
‘‘(I) the name of the registrant; 6
and 7
‘‘(II) an attestation that the re-8
search to be conducted with the small 9
quantities of manufactured substance 10
is consistent with the scope of the re-11
search that is the basis for the registra-12
tion. 13
‘‘(2) A
CTIVITIES INCLUDED.—Activities per-14
mitted under paragraph (1) include— 15
‘‘(A) processing the substance to create ex-16
tracts, tinctures, oils, solutions, derivatives, or 17
other forms of the substance consistent with— 18
‘‘(i) the information provided as part 19
of a notification submitted to the Attorney 20
General under section 303(n); or 21
‘‘(ii) a research protocol filed with an 22
application for registration approval under 23
section 303(g); and 24
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‘‘(B) dosage form development studies per-1
formed for the purpose of requesting an inves-2
tigational new drug exemption under section 3
505(i) of the Federal Food, Drug, and Cosmetic 4
Act (21 U.S.C. 355(i)). 5
‘‘(3) E
XCEPTION REGARDING MARIHUANA .—The 6
authority under paragraph (1) to manufacture sub-7
stances does not include the authority to grow mari-8
huana.’’. 9
(g) T
RANSPARENCY REGARDINGSPECIALPROCE-10
DURES.—Section 303 of the Controlled Substances Act (21 11
U.S.C. 823), as amended by subsection (a), is amended by 12
adding at the end the following: 13
‘‘(o) T
RANSPARENCYREGARDINGSPECIALPROCE-14
DURES.— 15
‘‘(1) I
N GENERAL.—If the Attorney General de-16
termines, with respect to a controlled substance, that 17
an application by a practitioner to conduct research 18
with the substance should be considered under a proc-19
ess, or subject to criteria, different from the process or 20
criteria applicable to applications to conduct research 21
with other controlled substances in the same schedule, 22
the Attorney General shall make public, including by 23
posting on the website of the Drug Enforcement Ad-24
ministration— 25
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•S 331 RS
‘‘(A) the identities of all substances for 1
which such determinations have been made; 2
‘‘(B) the process and criteria that shall be 3
applied to applications to conduct research with 4
those substances; and 5
‘‘(C) how the process and criteria described 6
in subparagraph (B) differ from the process and 7
criteria applicable to applications to conduct re-8
search with other controlled substances in the 9
same schedule. 10
‘‘(2) T
IMING OF POSTING.—The Attorney General 11
shall make information described in paragraph (1) 12
public upon making a determination described in 13
that paragraph, regardless of whether a practitioner 14
has submitted such an application at that time.’’. 15
SEC. 4. TECHNICAL CORRECTION ON CONTROLLED SUB-16
STANCES DISPENSING. 17
Effective as if included in the enactment of Public Law 18
117–328— 19
(1) section 1252(a) of division FF of Public Law 20
117–328 (136 Stat. 5681) is amended, in the matter 21
being inserted into section 302(e) of the Controlled 22
Substances Act, by striking ‘‘303(g)’’ and inserting 23
‘‘303(h)’’; 24
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•S 331 RS
(2) section 1262 of division FF of Public Law 1
117–328 (136 Stat. 5681) is amended— 2
(A) in subsection (a)— 3
(i) in the matter preceding paragraph 4
(1), by striking ‘‘303(g)’’ and inserting 5
‘‘303(h)’’; 6
(ii) in the matter being stricken by 7
subsection (a)(2), by striking ‘‘(g)(1)’’ and 8
inserting ‘‘(h)(1)’’; and 9
(iii) in the matter being inserted by 10
subsection (a)(2), by striking ‘‘(g) Practi-11
tioners’’ and inserting ‘‘(h) Practitioners’’; 12
and 13
(B) in subsection (b)— 14
(i) in the matter being stricken by 15
paragraph (1), by striking ‘‘303(g)(1)’’ and 16
inserting ‘‘303(h)(1)’’; 17
(ii) in the matter being inserted by 18
paragraph (1), by striking ‘‘303(g)’’ and in-19
serting ‘‘303(h)’’; 20
(iii) in the matter being stricken by 21
paragraph (2)(A), by striking ‘‘303(g)(2)’’ 22
and inserting ‘‘303(h)(2)’’; 23
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•S 331 RS
(iv) in the matter being stricken by 1
paragraph (3), by striking ‘‘303(g)(2)(B)’’ 2
and inserting ‘‘303(h)(2)(B)’’; 3
(v) in the matter being stricken by 4
paragraph (5), by striking ‘‘303(g)’’ and in-5
serting ‘‘303(h)’’; and 6
(vi) in the matter being stricken by 7
paragraph (6), by striking ‘‘303(g)’’ and in-8
serting ‘‘303(h)’’; and 9
(3) section 1263(b) of division FF of Public Law 10
117–328 (136 Stat. 5685) is amended— 11
(A) by striking ‘‘303(g)(2)’’ and inserting 12
‘‘303(h)(2)’’; and 13
(B) by striking ‘‘(21 U.S.C. 823(g)(2))’’ and 14
inserting ‘‘(21 U.S.C. 823(h)(2))’’. 15
SEC. 5. RULEMAKING. 16
(a) I
NTERIMFINALRULES.—The Attorney General— 17
(1) shall, not later than 6 months after the date 18
of enactment of this Act, issue rules to implement this 19
Act and the amendments made by this Act; and 20
(2) may issue the rules under paragraph (1) as 21
interim final rules. 22
(b) P
ROCEDURE FORFINALRULE.— 23
(1) E
FFECTIVENESS OF INTERIM FINAL RULES .— 24
A rule issued by the Attorney General as an interim 25
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•S 331 RS
final rule under subsection (a) shall become imme-1
diately effective as an interim final rule without re-2
quiring the Attorney General to demonstrate good 3
cause therefor, notwithstanding subparagraph (B) of 4
the undesignated matter following paragraph (4) of 5
section 553(b) of title 5, United States Code. 6
(2) O
PPORTUNITY FOR COMMENT AND HEAR -7
ING.—An interim final rule issued under subsection 8
(a) shall give interested persons the opportunity to 9
comment and to request a hearing. 10
(3) F
INAL RULE.—After the conclusion of such 11
proceedings, the Attorney General shall issue a final 12
rule to implement this Act and the amendments made 13
by this Act in accordance with section 553 of title 5, 14
United States Code. 15
SEC. 6. PENALTIES. 16
(a) I
NGENERAL.—Section 401(b)(1) of the Controlled 17
Substances Act (21 U.S.C. 841(b)(1)) is amended— 18
(1) in subparagraph (A)(vi), by inserting ‘‘or a 19
fentanyl-related substance’’ after ‘‘any analogue of N- 20
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 21
propanamide’’; and 22
(2) in subparagraph (B)(vi), by inserting ‘‘or a 23
fentanyl-related substance’’ after ‘‘any analogue of N- 24
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•S 331 RS
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 1
propanamide’’. 2
(b) I
MPORTATION AND EXPORTATION.—Section 3
1010(b) of the Controlled Substances Import and Export 4
Act (21 U.S.C. 960(b)) is amended— 5
(1) in paragraph (1)(F), by inserting ‘‘or a 6
fentanyl-related substance’’ after ‘‘any analogue of N- 7
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 8
propanamide’’; and 9
(2) in paragraph (2)(F), by inserting ‘‘or a 10
fentanyl-related substance’’ after ‘‘any analogue of N- 11
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 12
propanamide’’. 13
(c) D
EFINITION OF FENTANYL-RELATED SUB-14
STANCE.—Section 102 of the Controlled Substances Act (21 15
U.S.C. 802) is amended by adding at the end the following: 16
‘‘(60) The term ‘fentanyl-related substance’ has the 17
meaning given the term in subsection (e)(2) of schedule I 18
of section 202(c).’’. 19
SEC. 7. APPLICABILITY; OTHER MATTERS. 20
(a) I
NGENERAL.—Irrespective of the date on which 21
the rules required by section 5 are finalized, the amend-22
ments made by this Act apply beginning as of the date of 23
enactment of this Act. 24
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•S 331 RS
(b) RULE OFCONSTRUCTION.—Nothing in the amend-1
ments made by this Act may be construed as evidence that, 2
in applying sections 401(b)(1) of the Controlled Substances 3
Act (21 U.S.C. 841(b)(1)) and 1010(b) of the Controlled 4
Substances Import and Export Act (21 U.S.C. 960(b)) with 5
respect to conduct occurring before the date of the enactment 6
of this Act, a fentanyl-related substance (as defined by such 7
amendments) is not an analogue of N-phenyl-N-[1-(2- 8
phenylethyl)-4-piperidinyl] propanamide. 9
(c) S
ENSE OFCONGRESS.—Congress agrees with the 10
interpretation of the Controlled Substances Act (21 U.S.C. 11
801 et seq.) in United States v. McCray, 346 F. Supp. 3d 12
363 (W.D.N.Y. 2018). 13
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18
119
TH
CONGRESS
1
ST
S
ESSION
S. 331 A BILL
To amend the Controlled Substances Act with re-
spect to the scheduling of fentanyl-related sub-
stances, and for other purposes.
M
ARCH
3, 2025
Reported with an amendment
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